Clinical applications - MACS GMP Products - MACS GMP Quality - Controlled processes

Controlled processes

Our products are manufactured using the highest quality standards.

Standardized and strictly controlled industrial manufacturing processes are followed, including automated aseptic filling, lyophilization, and finishing. All steps – from master cell banks to final filled products – are carried out on qualified equipment by qualified and skilled employees.

  • Produced in a modern GMP-certified facility, including a full quality management system according to ISO 9001 & ISO 13485
  • EU GMP certificates for manufacturing of monoclonal antibodies (phase I/II), infusion solutions and aseptic filling
  • FDA-inspected for the CliniMACS® CD34 System

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Miltenyi Biotec Inc.
Phone: +1 800 FOR MACS
Fax:+1 877 591 1060
macs@miltenyibiotec.com
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